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Technology Enhanced Behavioral Activation Treatment for Substance Use

Primary Purpose

Substance-Related Disorders, Depressive Disorder, Behavioral Symptoms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LETS ACT
LETS ACT-SE
Treatment as Usual
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance-Related Disorders focused on measuring Mental Disorders, Mood Disorders, Behavioral Activation

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Between 18 and 55
  • Meet criteria for DSM-V substance use disorder
  • Elevated depressive symptoms (BDI ≥ 14)

Exclusion Criteria:

  • Limited mental competency (MMSE < 23)
  • Psychosis
  • The use of psychotropic medication for < 3 months
  • The inability to give informed, voluntary, written consent to participate

Sites / Locations

  • University of North Carolina at Chapel Hill
  • Southlight Healthcare

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Treatment as Usual

LETS ACT

LETS ACT-SE

Arm Description

Patients are offered substance use group therapy including relapse prevention. They are also provided medical consultation on an ongoing basis as needed.

The Life Enhancement Treatment for Substance Use (LETS ACT) involves the discussion of the treatment rationale, identification of values and goals in various life areas and activities in line with chosen life areas, and training for patients to identify their cycle of negative mood and behavior using forms to track their daily goals.

Participants assigned to the smartphone-enhanced LETS ACT (LETS ACT-SE) condition will be provided the exact same treatment as outlined in LETS ACT, except that LETS ACT-SE participants will record their daily goals using smartphone technology.

Outcomes

Primary Outcome Measures

Timeline Followback (TLFB)
The Time Line Follow Back is a self-report measure of drug and alcohol use.

Secondary Outcome Measures

Behavioral Activation for Depression Scale (BADS)
The BADS is a 25-item self-report measure of overall level of activity involvement
Reward Probability Index (RPI)
The RPI is a 20-item self-report measure used to assess environmental reward and punishment.
Beck Depression Inventory-II (BDI-II)
The Beck Depression Inventory is a 21-item self-report measure of depressive symptoms
Daily Goals Form
The Daily Goals Form is used to measure Treatment Engagement.
Texas Christian University (TCU) HIV/AIDS Risk Assessment Form
The TCU is a self-structured interview that measures HIV risk behavior in the domains of drug use and sex
Urinalysis
Urinalysis is a biological measure of substance use.
Breathalyzer
Breathalyzer is a biological measure of alcohol use.
Short Form Health Survey (SF-12)
The SF-12 is a 12-item self-report measure of mental and physical health-related functioning.

Full Information

First Posted
May 27, 2015
Last Updated
October 13, 2023
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT02707887
Brief Title
Technology Enhanced Behavioral Activation Treatment for Substance Use
Official Title
Technology Enhanced Behavioral Activation Treatment for Substance Use
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
December 2020 (Actual)
Study Completion Date
December 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to: test the effect of a smartphone enhanced LETS ACT (LETS ACT-SE) on frequency of substance use use functional magnetic resonance imaging (fMRI) to test the relationship between neuromarkers of reward sensitivity on frequency of substance use.
Detailed Description
Comorbid substance use disorder (SUD) and depression is highly prevalent and associated with elevated rates of post treatment relapse to substance use, HIV risk behavior, and associated poor mental and physical health outcomes. Further, rates of substance use and depression disproportionately affect minority groups and those living in poverty. Although efficacious, the often complex, specialized nature of CBT poses problems in its integration into substance use treatment programs. Budget cuts for mental health and substance use treatment both nationally and in the state of North Carolina, reduce availability of publically funded treatment programs and staff to patient ratios. To address this limitation, a behavioral activation (BA) treatment, the Life Enhancement Treatment for Substance Use (LETS ACT), was developed to treat depressive symptoms among a predominantly African American sample of low income illicit drug users currently receiving residential substance use treatment. Collectively, two Stage I studies and 1 year follow-up data from the investigators Stage II R01DA026424 indicate that compared to a control condition, LETS ACT is associated with significantly better outcomes for treatment retention, post treatment abstinence, HIV sexual risk behavior, depressive symptoms, and environmental reward. Although these strong outcomes suggest that LETS ACT may be ready for a Stage III dissemination trial, it is of note that there was a significant indirect effect of LETS ACT homework compliance on post treatment substance use and HIV sexual risk behavior via the theoretically proposed BA mechanism of action, environmental reward. In the context of limited access to care, these findings point to the need to identify cost-effective delivery-vehicles to increase treatment engagement outside of clinician sessions. Further, identifying neuroscience based biomarkers (neuromarkers) underlying key theoretical aspects of BA (i.e., reward sensitivity), and their relation to heterogeneity in BA treatment response among substance users with depression, are critical for the identification of accurately targeted interventions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance-Related Disorders, Depressive Disorder, Behavioral Symptoms, Risk-Taking, Sexual Behavior
Keywords
Mental Disorders, Mood Disorders, Behavioral Activation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
206 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment as Usual
Arm Type
Placebo Comparator
Arm Description
Patients are offered substance use group therapy including relapse prevention. They are also provided medical consultation on an ongoing basis as needed.
Arm Title
LETS ACT
Arm Type
Active Comparator
Arm Description
The Life Enhancement Treatment for Substance Use (LETS ACT) involves the discussion of the treatment rationale, identification of values and goals in various life areas and activities in line with chosen life areas, and training for patients to identify their cycle of negative mood and behavior using forms to track their daily goals.
Arm Title
LETS ACT-SE
Arm Type
Active Comparator
Arm Description
Participants assigned to the smartphone-enhanced LETS ACT (LETS ACT-SE) condition will be provided the exact same treatment as outlined in LETS ACT, except that LETS ACT-SE participants will record their daily goals using smartphone technology.
Intervention Type
Behavioral
Intervention Name(s)
LETS ACT
Other Intervention Name(s)
Behavioral Activation, Life Enhancement Treatment for Substance Use
Intervention Description
The Life Enhancement Treatment for Substance Use (LETS ACT)
Intervention Type
Behavioral
Intervention Name(s)
LETS ACT-SE
Other Intervention Name(s)
Behavioral Activation, Smartphone-Enhanced LETS ACT
Intervention Description
Participants assigned to the smartphone-enhanced LETS ACT (LETS ACT-SE) condition will be provided the exact same treatment as outlined in LETS ACT, except that LETS ACT-SE participants will record their daily goals using smartphone technology.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual
Other Intervention Name(s)
TAU
Intervention Description
Participants will receive the treatment typically provided to patients at the substance use treatment facility.
Primary Outcome Measure Information:
Title
Timeline Followback (TLFB)
Description
The Time Line Follow Back is a self-report measure of drug and alcohol use.
Time Frame
TLFB will be assessed from baseline to a 12-month follow up period.
Secondary Outcome Measure Information:
Title
Behavioral Activation for Depression Scale (BADS)
Description
The BADS is a 25-item self-report measure of overall level of activity involvement
Time Frame
BADS will be assessed from baseline to a 12-month follow up period.
Title
Reward Probability Index (RPI)
Description
The RPI is a 20-item self-report measure used to assess environmental reward and punishment.
Time Frame
RPI will be assessed from baseline to a 12-month follow up period.
Title
Beck Depression Inventory-II (BDI-II)
Description
The Beck Depression Inventory is a 21-item self-report measure of depressive symptoms
Time Frame
BDI-II will be evaluated from baseline to a 12-month follow up period
Title
Daily Goals Form
Description
The Daily Goals Form is used to measure Treatment Engagement.
Time Frame
Baseline to a 3-months post treatment.
Title
Texas Christian University (TCU) HIV/AIDS Risk Assessment Form
Description
The TCU is a self-structured interview that measures HIV risk behavior in the domains of drug use and sex
Time Frame
TCU will be assessed from baseline to a 12-month follow up period.
Title
Urinalysis
Description
Urinalysis is a biological measure of substance use.
Time Frame
Urinalysis is assessed from post treatment to a 12-month follow up period
Title
Breathalyzer
Description
Breathalyzer is a biological measure of alcohol use.
Time Frame
Breathalyzer will be assessed from baseline to a 12-month follow up period.
Title
Short Form Health Survey (SF-12)
Description
The SF-12 is a 12-item self-report measure of mental and physical health-related functioning.
Time Frame
SF-12 will be assessed from baseline to a 12-month follow up period.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Between 18 and 55 Meet criteria for DSM-V substance use disorder Elevated depressive symptoms (BDI ≥ 14) Exclusion Criteria: Limited mental competency (MMSE < 23) Psychosis The use of psychotropic medication for < 3 months The inability to give informed, voluntary, written consent to participate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stacey Daughters, Ph.D.
Organizational Affiliation
University of North Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-3270
Country
United States
Facility Name
Southlight Healthcare
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27604
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34730535
Citation
Paquette CE, Rubalcava DT, Chen Y, Anand D, Daughters SB. A Mobile App to Enhance Behavioral Activation Treatment for Substance Use Disorder: App Design, Use, and Integration Into Treatment in the Context of a Randomized Controlled Trial. JMIR Form Res. 2021 Nov 3;5(11):e25749. doi: 10.2196/25749.
Results Reference
derived

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Technology Enhanced Behavioral Activation Treatment for Substance Use

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